U.S. patent number 8,287,447 [Application Number 11/846,730] was granted by the patent office on 2012-10-16 for outer tube for natural orifice surgery.
This patent grant is currently assigned to Minos Medical. Invention is credited to Stephen Graham Bell, Christoph Gasche, Wayne A. Noda, Bradley J. Sharp.
United States Patent |
8,287,447 |
Gasche , et al. |
October 16, 2012 |
Outer tube for natural orifice surgery
Abstract
An outer tube for natural orifice surgery. The outer tube can
have interchangeable inserts to establish a desired size and number
of lumens. A distal tapered soft plastic plug may be provided to
cover the distal end of the tube. Different segments of the tube
may have different stiffness characteristics.
Inventors: |
Gasche; Christoph
(Klosterneuburg, AT), Bell; Stephen Graham (Rome,
IT), Noda; Wayne A. (Mission Viejo, CA), Sharp;
Bradley J. (Irvine, CA) |
Assignee: |
Minos Medical (Irvine,
CA)
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Family
ID: |
40408674 |
Appl.
No.: |
11/846,730 |
Filed: |
August 29, 2007 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20090062837 A1 |
Mar 5, 2009 |
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Current U.S.
Class: |
600/114; 600/127;
600/123; 600/129; 600/139; 600/121 |
Current CPC
Class: |
A61B
1/00089 (20130101); A61B 1/31 (20130101); A61B
1/00142 (20130101) |
Current International
Class: |
A61B
1/04 (20060101) |
Field of
Search: |
;600/114-115,121-125,139-140 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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WO 01/70097 |
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Sep 2001 |
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WO |
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WO 02/069841 |
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Sep 2002 |
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WO |
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Primary Examiner: Kasztejna; Matthew J
Attorney, Agent or Firm: Rogitz; John L.
Claims
What is claimed is:
1. An assembly for natural orifice surgery, comprising: an
elongated flexible outer tube defining a single main lumen; a first
insert slidably engageable with the main lumen and defining at
least one sub-lumen, the first insert substantially radially
filling the main lumen, the sub-lumen configured for slidably
receiving an endoscope, the first lumen having a first sub-lumen
configuration; and at least a second insert interchangeable with
the first insert and having a sub-lumen configuration different
from the first sub-lumen configuration, the inserts being provided
together as part of the assembly such that plural inserts are
provided to the user with the assembly so that the user can
configure the assembly to a number and/or size of working lumens as
desired by selecting an appropriate one of the first or second
inserts and engaging it with the main lumen of the flexible outer
tube; wherein the outer tube defines an open distal end, and the
assembly comprises a distal plug in the distal end; and wherein a
tether is attached to the distal plug, the distal plug being
pushable away from the outer tube using a surgical instrument to
disengage it from the outer tube, the tether facilitating retrieval
of the plug from the patient.
2. The assembly of claim 1, wherein the outer tube defines a distal
segment contiguous to a proximal segment, the distal segment being
more flexible than the proximal segment.
3. The assembly of claim 1, wherein the outer tube is made of a
sheath holding a coil, the distal segment having fewer turns of
coil per inch than a proximal segment.
4. The assembly of claim 3, wherein the portion of the sheath
around the distal segment has a hardness less than the hardness of
the portion of the sheath around the proximal segment.
5. The assembly of claim 1, comprising the endoscope.
6. The assembly of claim 1, wherein the insert extends
substantially the entire length of the outer tube while
accommodating the distal plug in the distal end.
Description
FIELD OF THE INVENTION
The present invention relates generally to systems and methods for
transanal and transoral surgical procedures such as for the
resolution of appendicitis, gall bladder maladies, and
diverticula.
BACKGROUND OF THE INVENTION
In the present assignee's U.S. patent application Ser. Nos.
11/601,199, 11/606,742, and 11/788,597, all of which are
incorporated herein by reference, devices and methods are disclosed
for natural orifice procedures. Specifically, devices and methods
are disclosed in which a medical instrument is advanced through the
mouth or anus of a patient to resolve maladies with organs such as
the gall bladder and appendix, and to treat diverticulosis. As
understood herein, such procedures can be facilitated by using a
relatively large outer tube through which one or more instruments
such as endoscopes, e.g., colonoscopes, may be advanced to
facilitate the desired procedure. It is to such outer tubes that
the present invention is directed.
SUMMARY OF THE INVENTION
An assembly for natural orifice surge includes an elongated
flexible outer tube defining a single main lumen. An insert is
slidably engageable with the main lumen. The insert defines one or
more sub-lumens and substantially radially fills the main lumen.
The sub-lumen is configured for slidably receiving an
endoscope.
If desired, the assembly may include a second insert that is
interchangeable with the first insert to define a number of
sub-lumens different from the number of sub-lumens defined by the
first insert. The reason for the multiple lumens in non-limiting
embodiments is to prevent instruments from being twisted and
entangled with each other.
In some embodiments, the outer tube defines an open distal end, and
the assembly includes a distal plug radially filling the distal end
around an outer diameter of the plug. The distal plug can be made
of soft non-absorbable plastic, and it tapers distally. The distal
plug may be hollow and may have an exterior contour that is
frusto-conical or rounded. In non-limiting implementations a tether
can be attached to the plug, and the plug can be pushed away from
the outer tube to disengage it from the outer tube with the tether
facilitating retrieval of the plug from the patient. The distal
plug may be defined by the insert itself, which can extend
substantially the entire length of the outer tube.
In non-limiting embodiments the distal segment of the tube is more
flexible than the proximal segment. This may be attained by
rendering the tube out of a sheath having a strengthening coil
wound therein, with the distal segment having fewer turns of coil
per inch than the proximal segment. In addition or in lieu of the
difference in the number of turns, the portion of the sheath around
the distal segment can have a hardness that is less than the
hardness of the portion of the sheath around the proximal portion.
Instead of differing hardnesses, a constant hardness may be used
with the distal portion having a thinner wall than the proximal
portion.
In another aspect, an assembly for natural orifice surgery includes
an elongated flexible outer tube defining a single main lumen. The
tube has an outer diameter of about twenty two millimeters and a
length of about one hundred centimeters to facilitate placement in
a patient through the anus into the colon.
In still another aspect, an assembly for natural orifice surgery
includes an elongated flexible outer tube defining a single main
lumen. The outer tube defines a distal segment that is contiguous
to a proximal segment, and the distal segment is more flexible than
the proximal segment.
In yet another aspect, an assembly for natural orifice surgery
includes an elongated flexible outer tube defining a single main
lumen. The outer tube defines an open distal end. A distal plug
radially fills the distal end around an outer diameter of the plug.
The plug is made of non-absorbable plastic and tapers distally.
In another aspect, a forward-viewing endoscope is advanced through
the anal orifice of a patient to the caecum, and then an outer tube
is advanced over the forward-viewing endoscope. The forward-viewing
endoscope is removed from the patient and a side-viewing endoscope
is then advanced through the outer tube to the caecum. The
side-viewing endoscope provides an image of an intended body
site.
The details of the present invention, both as to its structure and
operation, can best be understood in reference to the accompanying
drawings, in which like reference numerals refer to like parts, and
in which:
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view showing the outer tube, an insert
holding medical instruments, and a distal plug, with a replacement
insert shown nearby the outer tube;
FIG. 2 is a cross-section as seen along the line 2-2 in FIG. 1;
FIG. 3 is a cross-section as seen along the line 3-3 in FIG. 1;
FIGS. 4 and 5 are side views of two embodiments of the distal plug,
also showing, through the transparent outer tube, a tether attached
to each plug, with the plug in FIG. 4 shown pushed part way out of
the tube;
FIG. 6 is a perspective view of the proximal end of an alternate
overtube having a proximal plug with handle instead of an insert,
with portions of the replacement insert broken away for
clarity;
FIGS. 7 and 8 show an alternate balloon-implemented distal plug in
the inflated and deflated configurations respectively;
FIG. 9 is a side view of the distal end of an alternate outer tube,
with a vacuum ring formed around the periphery of the open distal
end;
FIG. 10 is a cut-away perspective view of the outer tube, showing
an insert completely advanced into the tube through the proximal
handle shown in FIG. 6;
FIG. 11 is a cut-away perspective view of the proximal portion of
the outer tube, showing an insert being advanced into the tube to
illustrate the longitudinal ribs ad slit of the non-limiting
insert;
FIG. 12 is a cut-away perspective view showing the distal end of a
forward-viewing endoscope; and
FIG. 13 is a cut-away perspective view showing the distal end of a
side-viewing endoscope.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring initially to FIG. 1, an assembly is shown, generally
designated 10, that includes a flexible hollow outer tube 12
fixedly or slidably holding one or more components such as but not
limited to an endoscope 14 such as a colonoscope and an ancillary
catheter 16, either one of which catheters may be connected to a
source 17 of vacuum. The endoscope 14 may extend from the open
distal end 12b of the outer tube 12 as shown to an endoscope
control hub 18 that is external to the patient. In this way, for
example, images of the colon from the endoscope 14 can be presented
on a monitor 20 to a surgeon. Additional components, e.g., a source
21 of insufflating fluid, may extend through or be engaged with
additional working lumens of the endoscope 14 and/or may be swapped
according to the stage of the procedure for the components 14, 16.
The additional components may include catheters for inverting
diverticula into the intestinal lumen, transmural suturing/clipping
devices, detachable ligating devices, and polypectomy snares.
The outer tube 12 may have a length of about one hundred
centimeters from its open proximal end 12a to its open distal end
12b, and may have a constant outside diameter "OD" of about twenty
millimeters. With this length, the tube 12 can extend completely
from the anal orifice of an adult patient to the caecum, as opposed
to ending at the sigmoid colon, thereby providing a pathway for
advancing an instrument such as an endoscope all the way from the
natural orifice to the caecum. As set forth further below, the
outer tube, 12 may be made from a transparent polyvinylchloride
(PVC) plastisol material with stainless steel reinforcing coil
embedded therein. The coil may have a diameter of about sixteen
mils. The transparent plastic body permits visualization of tissue
that may have been retracted into the tube 12 as well as
illumination through the tube 12 to illuminate the surgical
area.
The components 14, 16 may extend through respective working lumens
of the outer tube 12, but in the embodiment shown the components
14, 16 extend through respective working lumens of a flexible
insert 22 that, except for its lumens, substantially fills the
outer tube 12, both radially and longitudinally. That is, the
insert 22 is closely received in the large single central opening
of the outer tube 12, and may be replaced by a substitute insert 24
that has three working lumens 26 as shown. Any number of inserts
may be provided, so that a user can easily configure the assembly
10 to have as many or as few working lumens as desired, with
desired sizes for the working lumens, simply by selecting the
appropriate insert and engaging it with the outer tube 12.
Because only two instruments are intended to be used in the
non-limiting application shown, the insert 22 has only two working
lumens as shown which advantageously closely receive their
respective components 14, 16. The insert 22 may otherwise be solid
except for the working lumens.
As also shown in FIG. 1, the open distal end of the outer tube 12
may be filled by a distal plug 28 that can be tapered and that can
also be hollow if desired so that, e.g., the endoscope 14 can
extend out of it. The distal plug 28 may be separate from the
insert 22 or may be made integral therewith, and may be made of a
soft thermoplastic such as urethane that does not absorb water. The
distal plug 28 preferably fits loosely in the catheter and glides
easily over a scope. A lubricant 30 such as K-Y jelly or other
hydrogel may coat the outside of the outer tube 12 to facilitate
placement in the colon. The lubricant 30 may also coat one or more
of the lumens described herein.
FIGS. 2 and 3 show that the outer tube 12 may have differing
flexibility along different segments. More specifically, the
proximal portion 32 of the outer tube 12 may be stiffer, i.e., less
flexible, than the distal-most segment 34, which may be around ten
centimeters in length. The distal segment 34 is relatively more
flexible for initiating turns, while the proximal portion 32, while
retaining some flexibility, retains adequate column strength and
hoop strength for torque control and to prevent kinking and
collapse.
In one implementation, the outer tube 12 includes a cylindrical
sheath 36 made of, e.g., polyvinylchloride (PVC) plastisol, in
which is embedded a stainless steel reinforcing coil 38. As shown
in cross-reference to FIGS. 2 and 3, in the proximal portion 32,
the coil 38 has less spacing between adjacent loops than it has in
the distal segment 34. That is, the distal segment 34 has fewer
turns of coil per inch than the proximal segment. Furthermore, the
sheath 36 of the proximal portion 32 may be harder than it is
around the distal segment 34. In one non-limiting implementation
the sheath 36 has a 60 Shore A hardness around the proximal portion
32 and a 45 Shore A hardness around the distal segment 34.
One non-limiting method for making the tube 12 is to wind the coil
onto a mandrel in the desired number(s) of turns per inch, then dip
the mandrel into liquid plastic for each of the proximal and distal
segments, then bond the segments together. Or, when the same
hardness plastic but differing thicknesses are used, the mandrel
with coil is dipped into the liquid plastic in a way that results
in differing thicknesses of plastic, rendering the proximal and
distal segments unitary with each other.
FIG. 4 shows additional details of the distal segment 34 of the
outer tube 12. As shown, the distal plug 28 is frusto-conical in
shape, and may include a cylindrical stalk portion 40 that can be
advanced into the open distal end of the outer tube 12 to engage
the interior of the distal segment 24 in an interference fit. FIG.
4 depicts the plug 28 pushed part way out of the tube 12, it being
understood that a lip 42 formed between the frusto-conical and
cylindrical portions can abut the periphery of the distal end of
the tube 12 when the plug 28 is positioned as intended.
A user can advanced an instrument INST through the tube 12 to
dislodge the plug 28 from the tube 12 if desired, to, e.g.,
establish access to the bowel through the now-open distal end of
the tube. To this end, a tether 44, which can be seen through the
transparent wall of the tube 12, can be attached to the plug 28, so
that a gripper or forceps or other instrument can be used after the
tube 12 is removed from the patient to retrieve the plug 28 from
the patient. Alternatively, the tether can be attached to the tube
so that plug retrieval is accomplished when the tube is withdrawn
from the colon.
FIG. 5 shows an alternate distal plug 50 that can have a rounded
shape as shown, tapering down to a substantially flat distal face
52. Both distal plugs in FIGS. 4 and 5 prevent tissue entrapment
and provide a smooth leading edge for ease of pushing the outer
tube 12 through the bowel.
FIG. 6 shows a proximal handle 60 that can be advanced into the
open proximal end (single main lumen) of the outer tube 12 to adapt
the open proximal end for a smaller instrument. It is to be
understood that the handle 60 may simply include a short
cylindrical plug 61 (shown in phantom in FIG. 6) that is engaged
with the tube 12 in an interference fit and/or glued thereto, or it
may be part of or attached to one of the above-discussed elongated
inserts that extend substantially the entire length of the tube 12.
One of the above-discussed inserts may be advanced through the
proximal handle 60 into the outer tube 12.
In the embodiment shown, the handle 60 includes a disk-shaped
flange 62 that is radially larger than the tube 12. Four gripping
pins 64 extend proximally away from the disk 62 and are
substantially equidistantly spaced around the periphery of the
disk. A person can gasp the pins 64 to rotate the outer tube 12 as
desired.
The handle 60 is hollow, and a disk-shaped adapter cap 66, which
may be flexible plastic, is engaged with the disk 62. To this end,
the adapter cap 66 may be formed on its distal face with circular
protrusions that fit tightly within corresponding grooves in the
disk 62.
As shown, the proximal cap 66 forms at least one lumen 68 that is
smaller than the large main lumen of the tube 12. The lumen 68 of
the proximal cap 66 is sized to fit snugly around, e.g., the
endoscope 14 as shown, which may also function as a gas
insufflation catheter that may be connected to a source of bowel
insufflating fluid or the vacuum catheter 16 shown in FIG. 1. In
either case, a seal is formed around the catheter and small lumen
68, so that, e.g., if insufflating gas is infused into the bowel
through a catheter extending through the cap 66, it will not easily
leak out of the outer tube 12. Similarly, if the vacuum catheter 16
is advanced through the cap 66 to the distal end of the outer tube
12 to evacuate tissue into the tube 12, the vacuum is maintained by
the close cooperation of the small lumen 68 with the exterior wall
of the vacuum catheter 16. Additional small holes 69 may be
provided in the cap for closely receiving guidewires and other
components.
FIGS. 7 and 8 show an alternate distal plug 70 that is engaged with
the interior of an outer tube 72 which in all other respects may be
identical to the outer tube 12 discussed above. The distal plug 70
may be a toroidal-shaped inflatable structure such as a balloon,
and can be adhered to the inside surface of the tube 70 to
circumscribe the open distal end 74 of the tube. An instrument such
as the above-mentioned endoscope 14 can be advanced through the
distal plug 70 which, when inflated, provides a seal between the
instrument and the outer tube 72. The balloon can have a variable
tightness around the endoscope depending on user-established
inflation pressure. A small inflation tube or lumen (not shown) can
be provided along the length of the outer tube 72 to provide a
pathway for infusing and removing inflation fluid to the plug 70.
The plug 70 may be inflated as desired as shown in FIG. 7 to
accommodate the diameter of the particular instrument being
advanced through the outer tube 72 and then deflated as shown in
FIG. 8 to facilitate moving the instrument through the plug 70,
into or out of the patient.
FIG. 9 shows an outer tube 80 that in all essential respects is
identical to the tubes discussed above, except that its circular
distal face 82 establishes a circumferential vacuum port. The face
82 may be concave or V-shaped as shown, and one or more vacuum
holes 84 can establish fluid communication between the face 82 and
a vacuum lumen 86 that can extend the length of the tube 80 and
that can communicate with, e.g., the source of vacuum 17 shown in
FIG. 1. With this structure, the tube 80 can be positioned against
tissue and a vacuum established around its distal end, to
facilitate, for example, an inverting catheter system 88 to invert
tissue 90 into the tube 80. Details of the inverting catheter
system 88 are set forth in one or more of the above-referenced
patent applications.
The vacuum seal provided by the circumferential vacuum distal end
of the tube 80 stabilizes the tube 80 at the target site and
provides a closed chamber for cleansing the surgical site, which is
now isolated from the rest of the bowel. It also limits exposure of
colonic tissue in the event of unintended perforation.
FIGS. 10 and 11 show that in non-limiting implementations, the
insert 22 shown and discussed above may be formed with plural
longitudinal ribs 100 that are radially spaced around the otherwise
cylindrical body of the insert and that rise radially therefrom, to
facilitate engagement of the insert 22 with the outer tube 12. The
insert 22 may also be formed with a longitudinal slit 102 as shown,
through which access to the interior of the insert 22 may be
gained. The slit 102 preferably is biased to be closed.
FIG. 12 shows that a forward-viewing endoscope 104 include optics
106 that are disposed for imaging space directly in front of the
distal end 108 of the endoscope 104. In contrast, FIG. 13 shows
that a side-viewing endoscope 110 include optics 112 that are
disposed for imaging space through, e.g., a window 114 in the side
of the endoscope 110, i.e., space that is lateral to the distal end
116 of the endoscope 110. Or, the side-viewing endoscope may have a
distal end bent ninety degrees with respect to the axis of the
scope, with optics disposed to image space out of the bent distal
end, i.e., space that is lateral to the axis of the scope relative
to the organ in which the scope is positioned.
With the above structure, the following non-limiting procedure may
be performed. The forward-viewing endoscope 104 may be advanced
through the anal orifice of a patient to the caecum. Then, the tube
12 may be advanced over the endoscope 104, and the endoscope 104
removed from the patient. The side-viewing endoscope 110 may then
be easily advanced through the tube 12 to the caecum. It will
readily be appreciated that the tube 12 facilitates advancing the
side-viewing endoscope 110 into the bowel, which would otherwise be
rendered more difficult without the tube 12 since the side-viewing
scope 110 cannot easily provide a view ahead of where the scope is
being pushed.
The side-viewing endoscope 110 is useful for, e.g., viewing for
conducting a natural orifice appendectomy in accordance with one or
more of the above-referenced patent applications. It may now be
appreciated that the removable distal plug 70 may be pushed off the
end of the tube 12 when it is desired to invert excised tissue such
as an appendix into the tube 12 using a vacuum, with the tube 12
thus providing an advantageously large megalumen in which to draw
the tissue.
While the particular OUTER TUBE FOR NATURAL ORIFICE SURGERY is
herein shown and described in detail, it is to be understood that
the subject matter which is encompassed by the present invention is
limited only by the claims.
* * * * *